Cleared Traditional

K980054 - PALFIQUE ESTELITE

K980054 is an FDA 510(k) clearance for PALFIQUE ESTELITE, manufactured by Tokuyama America, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K980054 · Tokuyama America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
111d
Days
Class 2
Risk

K980054 is an FDA 510(k) clearance for the PALFIQUE ESTELITE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Tokuyama America, Inc. (Washington, US). The FDA issued a Cleared decision on April 27, 1998 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Tokuyama America, Inc. devices

FDA 510(k) Submission Details - K980054

510(k) Number K980054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1998
Decision Date April 27, 1998
Days to Decision 111 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 127d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 670
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K980054.
DYTRACT FLOW RESTORATIVE
K982395 · Dentsply Intl. · Aug 1998
3M DENT II SYSTEM
K981647 · 3M Company · Aug 1998
PRODIGY 2
K982148 · Sybron Dental Specialties, Inc. · Jul 1998
TOKUSO MAC BOND II
K980058 · Tokuyama America, Inc. · Apr 1998
SYNERGY
K974465 · Coltene/Whaledent, Inc. · Mar 1998
PALFIQUE ESTELITE PASTE
K980051 · Tokuyama America, Inc. · Feb 1998